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UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL), Unicel DxC SYNCHRON System HDL Calibrator

by Beckman Coulter, Inc.

510(k) K142985

Active European Union and United States

CE IVDR CE IVDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142985↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK142985 Date26 Feb 2015ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR, CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
JIT
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The UniCel DxC SYNCHRON System HDL Cholesterol Reagent (HDL) and HDL Calibrator are in vitro diagnostic reagents designed for the quantitative measurement of high-density lipoprotein (HDL) cholesterol in human serum or plasma. These reagents are intended for use with the UniCel DxC SYNCHRON System, a fully automated chemistry analyzer, to provide accurate and reliable HDL cholesterol levels as part of lipid profile assessments.

The HDL Cholesterol Reagent and Calibrator are supplied as single-use, ready-to-use reagents for clinical laboratory settings. The system operates in a non-sterile environment, with reagents stored at 2–8°C and protected from light. The calibrator ensures traceability to reference materials, and the reagents comply with FDA 510(k) clearance, IVDD, and IVDR requirements. The device is classified under Class II (device class 2) and is regulated under the FDA’s 862.1150 category for chemistry analyzers.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the UniCel DxC SYNCHRON System HDL reagent serve in laboratory testing?

    The UniCel DxC SYNCHRON System HDL Cholesterol Reagent is designed for the quantitative measurement of high-density lipoprotein (HDL) cholesterol in human serum or plasma. It is used as part of lipid profile assessments to help evaluate cardiovascular risk by providing accurate HDL cholesterol levels, which are a key indicator of heart health.

  • Are the HDL Cholesterol Reagent and Calibrator single-use or reusable, and how should they be stored?

    Both the HDL Cholesterol Reagent and Calibrator are supplied as single-use, ready-to-use reagents. They must be stored at 2–8°C and protected from light to maintain stability and performance. Since they are intended for clinical laboratory use, proper storage conditions are critical to ensure accurate and reliable test results.

  • What analyzer is required to use the HDL Cholesterol Reagent, and does it operate in a sterile environment?

    The HDL Cholesterol Reagent is intended for use exclusively with the UniCel DxC SYNCHRON System, a fully automated chemistry analyzer. The system operates in a non-sterile environment, meaning the reagents themselves do not require sterile handling, but standard laboratory practices for contamination control should still be followed.

  • How does the HDL Calibrator ensure accuracy and traceability in HDL cholesterol testing?

    The HDL Calibrator is included to ensure traceability to reference materials, which helps maintain consistency and accuracy in HDL cholesterol measurements across different tests. This calibration step is essential for reliable lipid profile assessments, as it aligns the analyzer’s readings with standardized benchmarks.

  • What regulatory pathways have been followed for this device, and what class does it fall under?

    The UniCel DxC SYNCHRON System HDL Cholesterol Reagent and Calibrator have undergone FDA 510(k) clearance, as well as compliance with the In Vitro Diagnostic Device Directive (IVDD) and In Vitro Diagnostic Regulation (IVDR). The device is classified under Class II (device class 2) and is regulated under FDA’s 862.1150 category for chemistry analyzers, reflecting its role in clinical chemistry testing.